2024年度の講演者情報
Speakers
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Carole Ackermann, EEA Cluster Portfolio Head, Novartis
A senior pharmaceutical leader with >20 years of experience with a holistic overview of clinical program/portfolio life-cycles. Ranging from early development to late phase/medical affairs, with a deep knowledge of the Novartis Development Organization and digital ecosystems.
Oscar Alcantar, Dir Clinical Operations, Clinical Operations, Maze Therapeutics
Dynamic Clinical Operations Leader with over 16 years of clinical research experience, including Phase I-III development and multiple US and Ex-US Marketing Authorization filings. Focus in oncology, CKD and rare disease, having led the largest Hemophilia A gene therapy study conducted globally. Possess a thorough understanding of cross-functional operational issues in drug development and strategy, with proven ability to rapidly pivot to meet business needs.
Matthias Alder, CEO, Gain Therapeutics, Inc.
Matthias Alder serves as Chief Executive Officer and Director of Gain Therapeutics. He joined the Company in 2021 as Chief Operating Officer with more than 25 years of transactional, operational, and business development experience in the pharmaceutical and biotechnology industries. Previously, Mr. Alder was Chief Business Officer at Autolus Therapeutics, a biotechnology company focused on developing CAR T-cell therapies for hematological and solid tumors, where he led the corporate development, legal, IP and HR functions. Prior to joining Autolus, he served as EVP of Business Development & Licensing and General Counsel of Sucampo Pharmaceuticals. During his tenure there, Mr. Alder established a late-stage development pipeline in orphan and rare CNS and oncology indications through acquisitions and strategic alliances. He has also held executive management positions at Cytos Biotechnology AG as EVP Corporate Development and General Counsel, and Micromet, Inc. as SVP Administration and General Counsel. Earlier in his career, Matthias was a partner in the Life Sciences Transactions Practice at Cooley LLP and in-house counsel for Novartis’ pharmaceutical business. Matthias earned his LL.M. in Comparative Law from Miami University, his lic. Iur. from the University of Basel and is a member of the Virginia, California, New York and Zurich bar associations.
Jodie Allen, PhD, Senior Director, Clinical Trial Diversity, AstraZeneca
Dr. Jodie Allen leads Clinical Trial Diversity at AstraZeneca and is responsible for global strategy and capability building in clinical development and operations. A medical sociologist by training, Jodie has 15+ years experience working across academic public health, life science consulting, and in pharma (Commercial and R&D). The red thread in her work is delivering large scale organizational change to improve patient access, experience, and outcomes. Her background in human behaviour in clinical settings, experience in technology implementation, and impact measurement are currently being combined to ensure that clinical trial populations reflect disease state populations in AZ sponsored trials.
Nicholas Alp, Chief Medical Officer, Clinical ink
Nicholas has more than 30 years of clinical research experience as an academic cardiologist, clinical trialist, and commercial drug development expert. Before joining Clinical ink, he was Senior Vice President and Head of Cardiometabolic Research at Medpace, a global clinical research organization. Previously, Nicholas was Vice President and Global Head of Cardiovascular Drug Development at ICON. He also simultaneously held appointments as a Consultant Interventional Cardiologist at the John Radcliffe Hospital, Oxford and a senior academic appointment in Cardiovascular Medicine at Oxford University.
Nicholas trained in medicine at London University and Oxford University, completed a PhD in Immunology at Cambridge University, with a further post-doctoral DM degree in Cardiology at Oxford University. He has also contributed to more than 70 peer-reviewed publications and books.
Moe Alsumidaie, Chief Editor, Editorials, Clinical Trial Vanguard
Moe Alsumidaie, currently the Chief Editor at The Clinical Trial Vanguard, is dedicated to providing the clinical research community with the latest and most detailed information on clinical trials. His extensive experience includes leading roles in enhancing clinical trial processes through innovative technology and strategic management. As the Head of Research at CliniBiz, he has significantly improved the efficiency and affordability of clinical trials using automation and AI, and at Annex Clinical, Moe spearheads the development of advanced data integration and visualization solutions. His career also includes impactful tenures at Applied Clinical Trials Magazine as an Editorial Advisory Board Member, as a guest lecturer at Rutgers University, and at leading organizations such as Stanford, Mt. Sinai, Abbott, Roche and Genentech, where he has been instrumental in optimizing clinical operations and implementing novel procedures in clinical trials quality control.
Nadir Ammour, DDS, MBA, Global Lead Clinical Innovation & External Partnership, Sanofi
Dr. Nadir Ammour began his career as an oral surgeon in public healthcare moving into clinical development. He is working to bring eHealth/Digital innovation in clinical development to deliver new medicines to patients faster. He led several projects in that space such as the Verkko remote trial, Connected Hospitals Network (EHRs); wearables trials, and on-line patient recruitment. Nadir is a member of the Executive Committee of the EHR4CR/InSite champion project. He led an EIT Health consortium project, EHR2EDC aiming at connecting healthcare and research. Dr. Ammour held various global positions previously at Wyeth, now at Sanofi. He is graduated in medical informatics, health economics and an MBA from Reims Management School, besides his Doctorate in Medical Dentistry
Solomon Babani, CEO, Crovelis
Sol Babani is a seasoned biopharma executive with over 25 years industry experience. The last 10 years he has been on the CRO side of the business, while the 17 years before that he was on the “sponsor” side in a variety of roles including: bench scientist, finance, project management, outsourcing and alliance management. Sol has spent time in large pharma (Pfizer and Novartis), biotech (Regeneron), and virtual development organizations (Auven/Celtic Therapeutics) and has thus seen the industry from many viewpoints. Mr. Babani also has a passion for innovation and how to better apply technology to the clinical research space, and has spoken at industry conferences on the topic of, “The Role of the CRO in the Healthcare Model of the Future.” With this experience, Sol has established himself as an expert in building and maintaining strategic partnerships, alliances, and collaborations. In his current role as CEO at Crovelis, Sol is responsible for leading the clinical operations team that services the clinical development needs of the Insud Pharma portfolio companies.
Dorothee B. Bartels, PhD, Associate Professor (Apl. Professor) for Public Health and Epidemiology, Medizinische Hochschule Hannover; Founder, HealthData-Advisors
Dorothee B. Bartels is the Global Head of Real World Evidence and Digital Sciences at UCB after having been Clinical and Real World Data Strategy Lead at X, Moonshot (Alphabet). Before, she used to be Corporate Head of Global Epidemiology at Boehringer Ingelheim (BI) for 10 years and for nearly two years Chief Digital Science Officer in the digital incubator of BI. She holds a Professorship of Epidemiology and Public Health at Hannover Medical School and is an Adjunct Professor at McGill University, where she lectures in the course of Advanced Pharmacoepidemiology. Her research is focused on secondary data use and data linkages, on innovative real-world data analysis approaches, new strategies for faster drug developments and approvals, and digital epidemiology, in particular combining AI/ML and traditional epidemiological methods.
Meri Beckwith, Co-Founder, Lindus Health Ltd.
Meri is the co-founder of Lindus Health. We run radically faster, more reliable clinical trials for life science pioneers. Previously a health and biotech VC investor, and serial clinical trial participant, where he saw how clinical trial outcomes could be improved for both sponsors and patients.
Frank Berger, MD, Expert Data & Analytics Solutions, Clinical Development & Operations, Boehringer Ingelheim
Physician (Dr. med.) with 20 years of experience in the pharmaceutical industry: Medical Affairs, Drug Development (Lead of international project teams), In-Licensing, (Pharmaco)Epidemiology, Controlling/Project Budgets/Analytics in Clinical Operations. He is currently the Global Clinical Operations, Head of Analytics at Boehringer Ingelheim Pharma GmbH & Co. KG.
Johanna Blom, PhD, Associate Professor, Behavioral Neuroscience; Chair, Ethical Committee for Research, University of Modena and Reggio Emilia
Dr. Johanna MC Blom, Associate Professor in Psychobiology and Pediatric and Behavioral Neuroscience, University of Modena; Former Associate Director of the Part-time Graduate Program in Developmental Psychology, and Associate Prof. of Psychobiology and Behavioral Brain Sciences, Johns Hopkins University, Baltimore, USA. Coordinator of the long-term follow-up of children with cancer and the use of psychotropic drugs, AIEOP; Member of PANCARE, SIOP, and the International Guideline Harmonization Group (IGHG) for the development of Psychosocial and Neurocognitive surveillance guidelines for survivors of childhood cancer. She is currently Chair of the Ethical Committee for Research of the University of Modena and Co-coordinator of the IMI-JU project FACILITATE. Expert in multidisciplinary behavioral toxicity studies linked to child abuse and severe and chronic diseases in childhood. Experience in longitudinal follow-up studies and innovative data driven network analysis as a tool to detect and predict the driving forces of disability using digital data. Her current interests lie in (digital) assessment tools to detect early signs of cognitive and behavioral problems and designing decision tree algorithms by using network analysis and dynamic mapping to understand the driving factors of the trajectory that moves a patient from being at risk to full blown pathology especially during adolescence and test the effectiveness of treatment by linking them to outcome values dynamically recorded in an ecologically valid way.
Emily Botto, Senior Research Assistant, Tufts University
Emily is a Senior Research Analyst at the Tufts Center for the Study of Drug Development where she works on a variety of studies focusing on clinical trial execution strategies and practices, diversity and inclusion, and patient experience and perspectives. Emily Botto has been published in peer-reviewed journals including Therapeutic Innovation & Regulatory Science, Nature Biotechnology, and JAMA Network Open and in trade journals including Applied Clinical Trials. She has given presentations at major industry conferences including Contracting and Outsourcing Conference, DIA Global Annual Meeting, Festival of Biologics, and the ACRP Annual Conference. Emily graduated from Brandeis University with BAs in Business and Communication and completed her MPH from Tufts University.
Jacqueline Bowman, Co-Founder, Foundation for the Rights of Citizens with Obesity
Jacqueline Bowman brings almost three decades of experience in shaping and transforming EU, national, regional and global health policy into reality. As a lawyer by education, with an MBA and expertise in Strategic Communications, she formerly led policy for the European Association for the Study of Obesity advocating on behalf of and building policy capacity for 20000+ Health Practitioners, Public Health professionals, researchers and students specialised in the research, prevention, diagnosis, treatment and long term management of the chronic disease of obesity. An expert with the European Commission, the European Medicines Agency, and the Belgian anti-discrimination Agency Working Group on equality data, Jacqueline is dedicated to improving obesity health outcomes and health system performance. In her volunteer role at the Foundation, she drives strategy and engagement, advocating for the legal rights of people living with obesity. A peer-reviewed author, Jacqueline's personal experiences with autoimmune Hashimoto’s and obesity enrich her professional insights. Fluent in French and with basic Dutch skills, she represents a blend of Guyanese (South America), British, and Belgian heritage.
Cezary Bregier Director, Global Clinical Solutions, AstraZeneca
Cezary Bregier has over 10 years of experience in clinical trials, mainly working closely to IRT-related business areas. He holds PhD in Cell Biology and Master’s degrees in Biotechnology and Agriculture. Currently, Cezary plays the IRT Business Platform Lead role, overseeing and driving the RTSM technological strategy with the focus on RTSM system capabilities, integrations, and process continuous improvement. In the past he has been leading the group of clinical IRT experts, Supply Chain Study Leads, and IRT UAT team as well as managing study-level IRT development work and testing activities.
Elizabeth Bristow, Director, Patient Recruitment & Retention, AstraZeneca
Liz Bristow is the Director of Patient Recruitment and Retention within the Clinical Trial Diversity (CTD) Team at AstraZeneca (AZ), where she is dedicated to embedding diversity and inclusion into the clinical development process. Liz has more than 20 years of experience in Clinical Trial Recruitment, Global Feasibility, and Site Intelligence having worked within CROs before moving over to Industry. Liz has gained a comprehensive understanding of the systemic barriers patients face due to social and economic disparities, and this underpins her current work in embedding clinical trial diversity action planning across AstraZeneca.
Natalia Buchneva, Risk Management Lead, Clinical Data & Innovation, UCB
More than 19 years in clinical research at various quality assurance and clinical operations roles at CROs and pharma. Recently focusing on risk-based quality management at UCB (e.g., study complexity assessments, risk-proportionate approach to study monitoring models, and risk-focused oversight of service providers). Extensive experience in managing regulatory inspections at the clinical investigator sites and sponsor. UCB's representative in EFPIA working groups for ICH E6 R3 (2020-2022) and US-EU GCP Inspection Mutual Recognition Agreement (2019).
Jacqueline Cannon, Chief Executive, The Lewy Body Society
The Lewy Body Society (LBS) registered charity 1114579, established in 2006, is the only registered Charity in Europe which is exclusively concerned with dementia with Lewy bodies (DLB). The charity's mission is to raise awareness of DLB amongst the general public and educate those in the medical profession and decision making positions about all aspects of the disease as well as to support and fund research into the disease. For ten years the LBS has raised awareness, provided support and information, and funded research into DLB, which is the second most frequent cause of age-related neurodegenerative dementia. In the UK approximately 100,000 people are thought to suffer from DLB. It is closely related to dementia occurring in people with Parkinson’s disease, referred to as Parkinson’s disease dementia (PDD) and which may affect a further 30,000 people. The needs of these two groups are different from people with other types of dementia. Both are caused by abnormal deposits of the protein alpha-synuclein in the brain which cause cell death. Together the two diseases are referred to as Lewy body dementia (LBD). Jacqui Cannon CEO of The Lewy Body Society lost her father to dementia with Lewy bodies 6 years ago and has worked tirelessly on a voluntary basis for the Society since its early days, taking on increasing responsibilities first as a secretary-treasurer then as CEO pro tem which turned into a permanent position, which she performed in addition to a full time job. Jacqui has 30 years’ experience as a Senior Business Analyst working for major companies including Accenture.
Peter Casteleyn, Director, Clinical Data Collection Solutions-EHR, The Janssen Pharmaceutical Companies of Johnson and Johnson
Over many years, I built up a broad experience in IT. Going from business oriented, working with senior executives on how IT solutions could best support them, to technically oriented knowhow in architecting IT infrastructure and applications. Roadmaps, investment decisions, application development, implementations and operations are very familiar. My passion for being intellectually challenged in order to create solutions, combined with my eagerness to guide and work with teams with a positive can-do mentality in order to grow, have been key elements in my career. Although I got to know multiple technologies and many different business areas, I see 2 elements that always return: the importance of insights from data for the business and team working. My servant leadership style, my optimism, my diplomatic attitude, my drive to come to solutions and my eagerness to learn new technologies and approaches are my key strengths. I’m passionate being in a business and innovation supportive role addressing technology challenges. My purpose is to grow the business through more efficient and smarter functioning thanks to insights from data and decision supporting technology solutions.
Abhishek Chatterjee, Solution Design Director, GCO-Health Data Insights & Design, Novartis
With over 12 years of experience in the Healthcare industry, I am Practice Head of Solution Design, Insights, Analytics & Data Science at GCO, Novartis, where I lead a network-based Product team of 40+ associates across solution design, data engineering, and analytics. I am passionate about problem-solving, and I have a strong track record of delivering innovative and impactful solutions and organizational transformation leveraging Data and Human-Centric Design thinking. Recently as a Digital transformation leader, I have successfully led and executed multi-million-dollar project delivery and transformation globally across Commercial and Drug Development, by collaborating with various Business Unit heads and Senior Leaders. I have also been instrumental in redefining and conceptualizing Planning as a Product and drove concept designs for digital Products across Portfolio acceleration, Site Selection, Competitive Intelligence, patient-centric solutions, Gen AI, and LLM-based use cases in Drug Development. Additionally, I serve as a strategic board advisor/Growth advisor, where I also partner with startups, scale-ups, and established organizations to accelerate their growth and transformation, using cutting-edge AI-driven strategies and tools.
Jenny Christal, PhD, Associate Director, Risk Based Quality Management, Jazz Pharmaceuticals
Jenny has over 25 years of Clinical Operations experience, focusing on clinical trial and program design, management, support, systems and processes, as well as regulatory inspection management. Her RBQM experience has involved refining early risk assessment processes and championing broader RBQM adoption, leading a post-acquisition project to establish RBQM strategy, process, and technology solutions, and now co-leading a team of Risk Managers supporting a broad portfolio of trials.
Stefania Collamati, DCT Operations Manager, Clinical Operations, Bayer SPA
I am a Senior DCT Operations Manager at Bayer and have 20+ years of experience working in Clinical Research within the pharmaceutical Industry. My area of focus has been study and project management, leading global study teams to plan, execute and deliver phase 2 and large phase 3 outcome trials in various indications. In my current role I provide input and expert guidance for strategic DCT planning and subsequent operational implementation, to ensure optimal DCT design and utilization for interventional clinical trials. I contribute to define the future DCT strategy within the company and infrastructure adaptation to support DCT adoption.
Jonathan Crowther, PhD, Head Predictive Analytics, PRD (OARS), Pfizer Inc.
Strategic Visionary in Digital Transformation & Analytics Leadership with Proven Analytics Portfolio Management Expertise With a keen eye for Strategic Vision, I've been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. My prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies. My role extends beyond mere strategy. I've championed an analytical development portfolio including in-house data & analytics transaction platform serving >1400 users, generative AI, and advanced modeling for business intel, ensuring robust analytical methodologies are in place, which has been pivotal for leadership and governance decisions. My expertise in Business Analytics and Product Analytics has been the backbone of this success, coupled with a budget management responsibility of >$5M. Building and nurturing relationships is at the core of my approach. I've continuously influenced key organizational stakeholders, ensuring the seamless adaptation and implementation of analytics and intelligence strategies. My proficiency in Engagement Management and Data Governance has been crucial in maintaining positive vendor partnerships, emphasizing quality delivery and continuous improvement. As a people leader, I've instilled a performance-centric culture, emphasizing Business Planning and actionable metrics. My commitment to Data Strategies and analytical thinking has ensured project and portfolio deliveries are not just timely but also rooted in process improvement. I've coordinated work with an agile mindset, ensuring products are delivered with consistency and precision. My technical acumen extends to Natural Language Processing (NLP), Business Intelligence (BI), data visualization, and cloud platforms including AWS, positioning me at the intersection of strategy and technology.
Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.
Keith Dorricott is an independent consultant and Director of DMPI Ltd since 2016. He developed his process thinking whilst at Kodak Ltd and is a Lean Sigma Master Black Belt. He has worked in two large CROs leading corporate process improvement for 10 years. He provides expert training and consulting services in metrics (KPIs, KRIs, QTLs), process improvement, and root cause analysis in clinical trials. He provides leadership to the Avoca Quality Consortium on metrics across the clinical trial spectrum including RBQM, QbD, and DCT. He is a member of the Scientific Advisory Board at the Centre for Pharmaceutical Medicine Research at King's College London. Keith's passion is improving the effectiveness and efficiency of processes by working with those on the ground who are running those processes.
Paul Duffy, Head, Global Clinical Site Partnerships, MSD
Currently leading efforts with MSD’s Clinical Site Partnership team. This includes developing a network of globally renowned clinical research sites and supporting long-term strategic relationships to increase and foster greater patient treatment choice, through clinical research studies; helping develop clinical research portfolios for partner sites and networks, and assisting increased delivery of company research through this global targeted network. Paul has over 20 years of experience in clinical development and has been building increased responsibilities and experience throughout this time. Previously he worked as Cluster Lead GCTO UK, Ireland, and South Africa, MSD Ltd, for several years. Prior to that, he was Clinical Research Director UK & Ireland, MSD UK Ltd. Paul has held several other roles within biopharmaceutical companies and CRO environments including project management, people management, and CRA roles in European, North American, and Japanese companies. He is a Registered General Nurse, holds a MA in Healthcare Leadership and Development, and Post Graduate Diplomas in Ethics and Law and Biomedical Research. For the past 5 years, Paul has been UK and Ireland country representative for TransCelerate Ltd, a not-for-profit organisation dedicated to the development and improved delivery of clinical trials.
Maria Dutarte, Executive Director, European Patients’ Academy on Therapeutic Innovation (EUPATI)
Maria Dutarte is the Executive Director of the European Patients’ Academy (EUPATI) since 2020. Maria has previously worked for the European AIDS Treatment Group (EATG) coordinating patient involvement in a number of training initiatives and scientific projects. She has also worked for different scientific and international organisations, e.g. French National Research Center for Scientific Research (CNRS), International AIDS Society (IAS), The Global Fund to Fight AIDS, Tuberculosis and Malaria and The International Foundation for Science (IFS). Her educational background is in International Education and Communications.
Heidi Egsgaard Frandsen, Director, Indication/Program Lead, AstraZeneca
Worked in the Industry for more than 22 years in various roles within Clinical Reach. Currently working as Director, Indication Programme Lead, overseeing our Asthma Portfolio from an Delivery and Operational perspective. I am based in Denmark
Lori Ellis, Head of Insights, BioSpace
Lori Ellis is the head of insights for BioSpace. She analyzes and comments on industry trends for BioSpace and clients. Previously she was a managing editor at Pharma Intelligence where she a variety of written, audio and visual media for in vivo subscribers and for Custom Content clients. In addition to being an editor and writer, she is an experienced host, moderator, and producer of webinars, podcasts, live discussions, and private events. She has received a Creative Muse award and several Vega and Adobe awards for collaborative narration projects. Areas she has covered span the drug development process, from pre-clinical to commercial stages. Her areas of expertise include the following as they relate to the life sciences industry: GenAI, DE&I, cybersecurity, and investments.
Mireille Ermens, Senior Director, Clinical Development Operations-Global Feasibility and Start-Up Support, CSL Behring
Mireille Ermens is a senior leader in the field of clinical research and healthcare management with a rich background spanning over two decades. Armed with a degree of Socio Medical Science with distinction from the University Ghent, Belgium, Mireille brings a unique blend of expertise in biochemistry, mathematics, statistics, and preventive healthcare. A true polyglot, Mireille is fluent in Dutch, French, and English, with proficiency in German and Spanish, reflecting a deep commitment to effective communication across diverse cultural landscapes. With a leadership style centered around "Building Bridges with and for People," Mireille has led clinical development operations teams, navigating challenges in rare and chronic diseases, high-volume infectious diseases, and seasonal vaccine environments. Currently serving as the Senior Director of Global Feasibility and Start Up Support at CSL Limited, Mireille spearheads strategic assessments of clinical trial feasibility, facilitating optimal business decision-making through meticulous recruitment-time-cost analyses and evaluation of execution options. Prior to this role, Mireille served as the Head of Global Site Management and Monitoring Oversight at CSL Seqirus, while advocating for global process consistency with patient-oriented oversight agility. Mireille's extensive experience also includes senior positions at Eli Lilly and Hoffmann-La Roche. Mireille began her career as an ICU Coordinator in Intensive Care at the University Hospital, Ghent, monitoring and caring for patients post-cardiac surgery, demonstrating a commitment to hands-on patient care. With a career trajectory marked by innovation, strategic vision, and a relentless pursuit of excellence, Mireille is a dynamic speaker who brings a wealth of knowledge and expertise to any discussion on clinical research, healthcare management, and leadership in the pharmaceutical industry.
Carme Esteve, EU Clinical Trial Submission Strategy Manager, Sanofi
Having 30 years of experience in Clinical Operations, held several positions in Clinical Research, Process, Quality and Line Management. Large experience in the implementation of the Clinical Trial Regulation at Europe level. Active member or leader of multiple working groups and initiatives within Clinical Operations group and beyond.
Alberto Fernandez, Senior Vice President, Global Clinical Operations, GSK
Alberto Fernández was born in Zaragoza (Spain) but grew up in Western Sahara and Madrid. Alberto got a Bachelor in Biology and an MSc in Animal Physiology at Universidad Complutense de Madrid. After joining Pharma, Alberto also acquired Business and Executive Education, holding a Global MBA and an Advanced Management Program from IESE Business School in Barcelona. Reuters Pharma 2024: Event briefing for Pedro Carrascal 4 After working in the lab in Academia, Alberto joined the Pharma Business at Zeneca (later AstraZeneca) Spain in 1993 as a CRA. Since then, he has held numerous roles always in the R&D organisation, with a passion for developing medicines and vaccines and making them available to patients as fast as possible. His tenure covers Local, Regional and Global positions in Clinical Operations, initially in AZ, where he stayed for 26 years and since December 2019, in GSK as SVP of Global Clinical Operations. As SVP of Global Clinical Operations in GSK, he is accountable for the operational planning and delivery of the complete portfolio of studies (all Phases, all Therapeutic areas) in the pipeline of GSK and its subsidiaries. Having a large team spread across 40 countries and partnering with Investigational Sites and Suppliers is part of his day-to-day. In addition to innovation, diversity, equity, inclusion, and sustainability are two important focus areas applied to deliver value and efficiency in all clinical trial activities. Alberto is married, has three sons, and has an extensive international career, living in six countries across Europe, Africa, and South and North America. Curious by nature, he likes outdoor activities in mountains and wide-open terrain when not at work.
Hubert Filipczak, Director, Global Clinical Solutions, AstraZeneca Pharma Poland Sp zoo
Hubert Filipczak is a professional with over a decade of experience in various leadership roles within AstraZeneca Pharma Poland and its global operations. He holds a Master's degree in Economics and Postgraduate studies in Bio-statistics, providing him with a unique blend of business acumen and analytical expertise. Currently serving as the Director of Global Clinical Solutions (GCS), Hubert plays a pivotal role in driving the delivery of technology and associated processes for the BioPharmaceuticals and Oncology R&D organization. With a team of approximately 60 experts across three distinct groups, Hubert oversees Interactive Response Technology, User Acceptance Testing/System Validation, and Event Adjudication. His strategic leadership focuses on life-cycle management and continuous improvement of IRT technology, ensuring operational excellence, technical innovation, and adherence to quality and compliance standards. Throughout his career at AstraZeneca, Hubert has consistently demonstrated his ability to lead high-performing teams and leading strategic initiatives, making him a valuable asset in driving innovation and excellence within the organization.
Gandolf Finke, PhD, Founder & Managing Director
Gandolf is co-founder and managing director at Mika Health by Fosanis since 2017 headquartered in Berlin, Germany. Mika is the leading digital therapeutics platform in oncology having served >100.000 cancer patients and active across EU and US markets. Gandolf's engineering background and roots in the medical field guided him to work in digital health for more than 15 years in different roles across Europe and the US. Gandolf holds degrees in engineering from Univ. Karlsruhe/MIT and a PhD from ETH Zurich.
Mette Flindt Heisterberg, PhD, Competency Development Specialist, Clinical Operations Office, Global Trial Portfolio, Novo Nordisk AS
Mette Flindt Heisterberg, Competency Development Specialist, Novo Nordisk. Mette has a background in academic research and has a PhD degree from Basic and Clinical Research in Musculoskeletal Sciences, Faculty of Health and Science, University of Copenhagen. Since 2017 Mette has worked at Novo Nordisk within Clinical Operations as trial manager and within the latest years as project manager on different innovative improvement projects.
Joanna Florek-Marwitz, Head, Risk Management & Data Quality, UCB Biosciences
Joanna brings 20 years of managerial and technical experience in clinical research industry delivering business and data transformation solutions. She has extensive experience in clinical and non-interventional trials operations across all therapeutic areas and is an expert in applying program management, integrated risk-based quality management, process improvement, innovation, and change management methodologies. Joanna has led many large-scale, global initiatives within the pharmaceutical industry that include clinical data management and analytics, process optimization and technology improvements, driving operational efficiencies and working relationship with customers for operational service excellence. Her technical experience, background in analytics and process improvement brings critical value to technology implementation ensuring trial execution for patient safety and reliable data to answer the trial scientific questions.
Maria Florez, Research Consultant, Tufts Center for the Study of Drug Development
Maria Florez is a research consultant affiliated with the Tufts Center for the Study of Drug Development. Her research looks at the impact of digital transformation in clinical research; practices, strategies, and incentives driving improvements in the pharmaceutical R&D process; and the economics of new drug development. Maria has been a researcher and strategist in the healthcare sector for more than a decade. She has held positions at Cleveland Clinic, New York-Presbyterian Hospital of Columbia, and Cornell Universities. Maria holds a bachelor’s degree in economics and master’s degree from The Fletcher School of Law and Diplomacy at Tufts University.
Alison Foster, VP, Development Strategy and Growth, Fortrea
Over 26 years of industry experience across both pharmaceutical and CRO companies. Leadership of Project Management and Stratgeic Delivery departments over the last 12 years. Currently heading up departments covering strategy, feasibiity, site engagement and partnerships, digital health and innovation and patient recruitment and enagement.
Ricardo Gaminha Pacheco, Strategic Partnering, Business Development & Licensing Director, Insilico Medicine
Entrepreneurial MD with experience in Public and Private Healthcare turned Pharma & Biotech Executive, where in the last decade or so, has held multiple roles of increasing responsibility and leadership levels at National, Regional European and Global levels in worldwide reknown Pharmaceutical & Biotech companies such as Novartis, AstraZeneca and Roche, having more recently taken a porfolio career approach, kickstarting independent entrepreneurial, investor and consultant projects of my own, being Co-Founder of NeuroSov, Partner at BSG Pharmaceuticals, Founding Investor of CORE Angels and Founder of NextGeneration MD Consulting.
Estrella Garcia Alvarez, PhD, Director, Global Clinical Operations, R&D, Almirall SA
Estrella began her ‘scientific odyssey’ at the University of Navarra, Spain, where she gained a PhD in Genetic Toxicology. With a post-doctoral position at ICI in the UK. Subsequently, Estrella returned to Spain where she joined Almirall as a Clinical Research Scientist. Since then, she has amassed a 25-year career with the company- taking on roles of increasing demand and responsibility. Estrella leads her group and is responsible for clinical trials worldwide. Since Almirall does not have affiliates fully involved in clinical development, the company externalizes all clinical trials, with a strategic focus on keeping only core competencies. In this capacity, Estrella has worked with dozens of CROs and service providers managing Phase I to Phase IV clinical trials of all sizes, from small single-center studies to global programs involving hundreds of sites and thousands of patients. Her responsibility covers the selecting, negotiation, contracting, managing, and final evaluation of the CROs responsible for the worldwide clinical development, in order to deliver on the agreed timelines, quality, and cost. She was responsible for ensuring Clinical Development for Aclidinium bromide from an Operational point of view in COPD. Since November 2014, fully focused on DERMATOLOGY development with 3 R&D sites in Europe, the biggest in Barcelona (Sant Feliu de Llobregat), the second in Reinbek, and the most recent one acquired in Swizerland-Lugano- (Polichem). But also in close collaboration with Almirall US, a company that was acquired by Almirall back in December 2013 (AQUA Pharmaceuticals). Managing Global Clinical Trials from Phase I to Phase IV, in several therapeutical areas Respiratory, Dermatology, Migraine, Allergy, and Gastrointestinal. CRO Selection and Management. Deliverables in Clinical Trials. Metrics and Performance in Clinical Trials. Active participant in forums like PCTs, PCMG, DIA Clinical Forum, Outsourcing Clinical trials in Europe Conferences, etc.
Laurence Garret, Therapeutic Area Lead, Clinical Operations, MSD
Prior to joining MSD, Laurence Garret had occupied different positions in clinical research operations: From Clinical Research Associate to Global Study Delivery Team Leader within AstraZeneca France. Manager of clinical team within Lundbeck France and Regional Study Advisor for various countries in Europe, Africa, and the Middle East within Lundbeck Headquarters. Laurence joined MSD France in 2016 as a Senior COM and became County TAH in 2018. Leading the EMEA DICT Network since 2023. Education: Clinical Research Education within Paris Sorbonne Nouvelle. Certification of Executive Education on Leadership and Management (HEC Paris Business School).
Bernhard Glombitza, Head, Clinical Operations EMEA and APAC, Bayer
Dr. Bernhard Glombitza has over 25 years of leadership experience in the healthcare industry, currently he is the Head Clinical Operations & Customer Engagement EMEA & LATAM, VP at Bayer, a global leader in life sciences and innovation. He is responsible for ensuring excellence and value in clinical trial quality and delivery across the portfolio of Phase I to IV clinical studies, covering a wide range of therapeutic areas and indications (Cardiovascular, Immunology, Womens Health, Oncology, Radiology, Cell and Genetherapy). As a pharmacist by training with a PhD in pharmaceutical technology, he has a deep understanding of the science and the regulatory environment behind clinical research and development. He is passionate about improving healthcare outcomes and patient access to innovative treatments, by collaborating with internal and external stakeholders, inspiring and challenging my team as a catalyst and visionary leader.
Bola Grace, PhD, MBA, Professor, University College London
Professor Bola Grace has decades of leadership experience across multiple sectors across pharma, biotech, and academia. She enjoys collaborative research and development as well as the application of data science in women's health, digital health, inclusive innovation, and health inequalities. She is a Royal Academy of Engineering Visiting Professor of Healthcare Engineering and Inclusive Innovation, an Honorary Professor of Practice at UCL, and MD at Cambridge Matrix. She has a PhD from University College London and an Executive MBA from the University of Cambridge Judge Business School.
Susannah Guinee, Clinical Operations Lead, Product Development Global, Roche
Susannah Guinee is Clinical Operations Lead in Product Development Global at Roche. In parallel with clinical operations, her career's focus has been accelerating clinical trials through technology; whether through tools, processes, or systems. She has an MA (Cantab) BA Hons in Natural Sciences from the University of Cambridge.
Duncan Hall, CEO, Executive, Triumph Research Intelligence Ltd
A visionary leader with over two decades of experience in the dynamic landscape of the life science industry. As the CEO and Founder of TRI - The RBQM Experts, Duncan has carved out a niche for himself as an expert in Risk-Based Quality Management (RBQM). With a keen understanding of solution implementation, Duncan has propelled TRI to the forefront of the industry, offering innovative approaches to monitoring and managing risk in clinical trials. His unwavering commitment to excellence and his ability to anticipate industry needs make him a driving force in shaping the future of RBQM.
Alex Hammond, Business Development Manager, National Institute of Health and Care Research (NIHR)
Alex Hammond is a Business Development Manager for the National Institute of Health and Care Research (NIHR) and his role is to advise life sciences companies, funders, and researchers on the Network’s capability and capacity to deliver their research pipeline in the UK. Alex works closely with the Network’s portfolio of free services alongside an array of world-renowned expertise from patient groups to clinical and academic research professionals. He has a close relationship with all clinical specialties with strong links specifically in Oncology, Oral and Dental, and Surgery. Alex joined the CRN in September 2021 previously having had over 15 years working in the NHS clinically, operationally, and in Business/Service Development. This included working in programme managing the COVID-19 Vaccine roll out in Leeds, UK, and designing and implementing large-scale system-wide services in Yorkshire and Humber.
Melissa Harris, Global Head, Patient Recruitment & Engagement, Fortrea
Melissa has over 20 years of industry experience with five years tenure at Fortrea creating patient centric patient engagement and recruitment programs for all phases of studies including pediatric, rare and hard-to-reach patient populations. Melissa works to harness the benefits of applying innovative solutions toward successful patient recruitment campaigns while driving health literacy and patient-led trials to reduce study burden and facilitate the study into everyday life. Melissa leads Fortrea’s “Voice of Patient” program which is used to drive patient insights into every step of the drug development paradigm.
Christopher Hart, Partner, Co-Chair, Privacy and Data Security Group, Foley Hoag LLP
Chris Hart is a litigation partner and co-chair of the Privacy and Data Security group at Foley Hoag LLP, a leading law firm with a global reach and a reputation for excellence. With nearly two decades of civil litigation and human rights experience, Chris helps clients navigate complex and evolving data privacy and cybersecurity challenges, from compliance and incident response to government investigations and litigation. As a certified privacy professional and a recognized leader in the field, Chris advises clients across various industries and geographies on their data management and governance practices, including their obligations under comprehensive data protection laws (such as CCPA, GDPR, PIPEDA), and other domestic and international frameworks (such as the TCPA). Chris has extensive teaching experience as a part-time lecturer at Northeastern University School of Law, where he designed and taught courses on data privacy regulation and compliance. Chris has a vibrant pro bono practice, for which he has received significant recognition. Chris is a passionate advocate for diversity, equity, and inclusion, and leads the firm's practice in counseling clients on their DE&I practices and managing investigations relating to DE&I.
Farrell Healion, Senior Director Emerging Technologies, Global Clinical Solutions, AstraZeneca
Farrell Healion is currently Senior Director Emerging Technologies, Global Clinical Solutions at AstraZeneca, where he leads the operational readiness delivery to scale up new technologies to be used in their clinical trials. He previously led their Digital Patient Solutions team that deliver patient-facing Digital Health Technologies(DHTs) such as eCOA across the AstraZeneca portfolio. Starting out as an eCOA Developer at CRF Health, Farrell then moved through various technical leadership roles eventually leading the Technical and Project Management Office in Signant Health before moving to AstraZeneca. He is passionate about scaling up the use of patient and site-centric new DHTs in Clinical Trials, getting involved with various industry work groups such as DTRA and the eCOA Consortium. He is also the 2023 winner in Pharmatimes International Clinical Researcher of the Year award in the Decentralised Solutions category.
I am a Children and Young People’s Nurse by background but have worked in research delivery for the last 6 years within the National Institute for Health and Care Research, Clinical Research Network (CRN) Greater Manchester. My research experience includes both non-commercial and commercial delivery, across a variety of specialities and settings including NHS and non-NHS. I am the Matron for the CRN Agile Research Team and lead an incredible team of both clinical and non-clinical staff, taking research out into the community and finding novel ways to increase inclusion and diversity in research. I am the ENRICH lead (Enabling Research in Care Homes) for Greater Manchester and am focused on building our regional social care research capacity and capability. I am also part of the national CRN Direct Delivery Team Leadership Group, driving forward transformation of research delivery in the UK.
Steffen Hess, Head of Health Data Lab, BfarM
Dr. Steffen Heß, an experienced researcher in the field of pharmacoepidemiology and health services research, has been leading the Health Data Lab at the Federal Institute for Drugs and Medical Devices in Bonn since 2020. With a career marked by a strong background in big data, he has significantly contributed to the advancement of healthcare research using secondary data. In addition to his leadership role, Dr. Heß is an active participant in several international initiatives, playing pivotal roles in the Joint Action TEHDAS2, EHDS2 Pilot, and HDP4Germany. He is also a member of the Big Data Steering Group of the European Medicines Agency (EMA), showcasing his commitment to leveraging big data for healthcare innovation and improvement. He is an esteemed author and co-author of scientific publications and is well-rooted in the scientific community.
Jameka Hill, Director, Patient Engagement & Advocacy, Moderna, Inc.
Jameka Hill is the Senior Director and Global Head, Clinical Trial Health Equity at Moderna where she is at the forefront of establishing and guiding the company's strategy to enhance patient involvement, deepen patient and community health partnerships, and ensure diverse and inclusive clinical trials. For over two decades, Jameka has focused exclusively on increasing awareness and improving access to clinical trials as a care option for women, older adults, racial-ethnic minority groups, patients living with rare diseases, and vulnerable populations including pregnant women and pediatrics. Jameka is an avid health literacy and community engagement advocate who strongly believes in the importance of collaborating with internal stakeholders and external thought leaders to improve heath equity around the world.
Rachel Horovitz, VP, Product Strategy, Medidata AI
Rachel Horovitz is a VP of Product Strategy at Medidata AI. Over the past 4 years, she has led the conceptualization and launch of innovative analytics solutions to improve decision making in clinical trial planning and execution for life science customers. Examples include the launch of an offering to increase diverse representation in clinical trials, as well as an offering to inform trial recovery planning during the peak of the COVID-19 pandemic. Prior to her current role, Rachel spearheaded cross-functional strategic initiatives and corporate strategy projects at Medidata. Before Medidata, Rachel advised healthcare and technology companies on strategic issues and decisions at Bain & Co. and Rothschild. She holds a Master in Biomedical Engineering from the University of Bern in Switzerland, an MBA from the MIT Sloan School of Management and a BS in Economics from The Wharton School, University of Pennsylvania.
William Illis, Global Head, Collaboration & Technology Strategy Clinical Development, Novartis Pharmaceuticals
Bill is the Head of Collaboration and Technology Strategy, in the Clinical Development and Analytics function at Novartis and is currently responsible for developing the Analytics strategy and initiating improvement projects. He has developed and led large-scale technology and business process transformation projects in data and digital across the pharma R&D landscape. He was appointed as lead for the Transcelerate Digital Data Flow initiative in June 2018. Bill has over 25 years of industry experience in R&D spanning subject areas of Cancer Epidemiology, Health Care Cost/Utilization Research; Preclinical Safety, and Clinical Development and Regulatory Affairs, and functional experience in Data Management, Programming, Statistics, Data Standards, Data Governance, Information Technology and Operations. He holds a Master’s Degree in Public Health (Biostatistics) from the University of Michigan and a Bachelor’s degree in Psychology from Providence College.
Paul Jacobs, Associate Director, Development Innovation, Regeneron Pharmaceuticals, Inc.
Paul Jacobs is Associate Director of Global Development Innovation at Regeneron. He is part of a function responsible for enabling clinical trials innovation by bringing innovative thinking, tools and techniques to the table through an innovation pipeline process. Before joining Regeneron in 2021, Paul worked in innovation roles at LEO Pharma as Head of Innovation, helping to establish and grow the R&D Data and Analytics function and, before that, as a founding member of the LEO Pharma Innovation Lab. Paul has also held roles in consultancy with Frog (Capgemini Invent) as Head of the UK Life Science Practice and various Medical Editing, Digital Strategy and Client Service roles at Publicis Healthcare, Sonic Boom and Nucleus Group companies. Paul received his Masters Degree in Biomedical Sciences from King’s College, London and his Bachelor’s degree in Biological Sciences from The University of Salford.
Estelle Jobson, EUPATI Fellow and Patient Expert
Estelle Jobson is a EUPATI Fellow and patient expert living with endometriosis. She has an MSc in Publishing from New York University, attended on a Fulbright scholarship, and decades of experience in editing, communications, and publications management for health-related, academic, and educational institutions. In 2019, she became a founding patient partner at the Geneva University Hospitals (HUG) project (PartnerREC), supporting Swiss-based investigators with embedding patient-centricity in their studies, as well as co-creating and co-teaching a training course for researchers and patients about working in partnership. Her key interests include: the gender health gap, patient and public involvement in R&D,patient-centricity in trial design and communications with participants, lay summaries, risk-benefit communications, and patient-reported outcomes. She serves on boards with life sciences companies and as a patient peer reviewer for The British Medical Journal.
Tom Johnson, Senior Director, Life Sciences & Health IT, Exostar
Tom Johnson is a seasoned professional who has devoted the last decade to optimizing the clinical study process for life sciences companies, focusing on reducing technical burdens and enhancing efficiency in study start-up and application access management. Exostar's expansive community includes half of the world’s largest pharmaceutical companies, over 30,000 organizations, and 100+ connected applications, over 700,000+ individuals working in thousands of sponsors, CRO and site locations worldwide. With a Bachelor of Science in Industrial Engineering from The Georgia Institute of Technology, Tom brings a unique blend of academic expertise and practical experience to his role, driving impactful solutions within the life sciences industry.
Tina Karunaratne, Founder and CEO, Karuna Integrated Clinical Services
Tina is the Founder and CEO of Karuna Integrated Clinical Services (KICS), a niche Clinical Research Organization. She also serves as a Consultant to startup biotech/pharma companies. Tina also serves on the Board of Directors for two non-profit organizations - Children Across America (CAA), which focuses on enriching the lives of minority children in STREAM (Science, Technology, Reading, Engineering, Arts, and Mathematics) and, more recently, Pathways to Trust. This organization focuses on the needs of patients and families battling rare diseases and facing hurdles to care. She is an Adjunct Instructor at Northeastern University’s Masters in Biotechnology Program. Tina has a Doctoral degree in Law and Policy (Northeastern University) and a Master of Science in Regulatory Affairs (Regis College).
Nada Khan, Clinical Data Quality Lead, CPRD
Dr. Nada Khan is Clinical Data Quality Lead for the Clinical Practice Research Datalink (CPRD). She is also an Academic Clinical Lecturer in General Practice at the University of Exeter and a practising general practitioner (GP). She has extensive experience in working with the CPRD for research and exploring data quality within the database, as well as working to develop solutions for expanding the use of CPRD for clinical trials research.
Garo Kiledjian, Founder & CEO, SGM Alliance
Garo Kiledjian is the Founder, President, and CEO of SGM Alliance, a 501c3 nonprofit that focuses on educating and advocating for inclusive Sexual and Gender Minority (SGM) participation in clinical trials, life sciences, and the evolution of healthcare. Garo also serves as the Chief Operating Officer for Trialogic, a Site Network for one of the largest global LGBTQIA+ healthcare providers. Having served in multilevel roles within administration, research, pharmacy, operations, and finance, Garo brings a versatile skill set to his leadership role. He also serves on the Membership Planning Committee for Society for Clinical Research Sites (SCRS) and is on the Executive Committee for the National LGBTQ Task Force-one of the oldest social advocacy groups that focuses on legislative and policy changes at the grassroots level in Washington, DC. He is passionate about DEI and offers a unique perspective on how the intersectionality of race and ethnicity overlap with gender and sexuality. Garo earned his Bachelor’s from UCLA and studied Leadership and Global Strategy at Woodbury’s Graduate School of Business.
Olgica Klindworth, Vice President, Data Quality & Risk Management Solutions, Medidata, Dassault Systemes
Olgica Klindworth is Vice President for Data Quality and Risk Management at Medidata, where she focuses on developing Data Quality solutions, including creating AI-driven data surveillance approaches. Before joining Medidata, Olgica dedicated 17 years to PPD, with a decade spent in data management leadership roles. During her tenure, she built Data Management capabilities and supervised the execution of numerous clinical trials spanning various therapeutic areas. Olgica also played a pivotal role in developing Data Analytics and Centralized Monitoring processes and capabilities at PPD. Olgica holds a Bachelor of Science degree in Microbiology from the University of Texas at Austin and a Master of Science degree in Analytics from Texas A&M University.
Christoph Koenen, Head of Clinical Development & Operations, Pharma Research & Development, Bayer
Christoph, an experienced medical leader, heads Bayer's Global Development and Clinical Operations, overseeing the entire portfolio's clinical development. With a patient-focused approach, he leads teams from early development to late stages. As the former Chief Medical Officer at Otsuka, Christoph managed diverse development and medical functions globally. His expertise spans roles at Bristol-Meyers Squibb and Novo Nordisk, emphasizing cardiovascular medicine. Christoph, a 1994 graduate of Ruprecht-Karls University, Heidelberg, Germany, holds an MBA from Schiller International University and is board-certified in internal medicine and diabetology. His fusion of medical knowledge, business strategy, and regulatory proficiency drives impactful contributions to global patient access and clinical innovation.
Sylwia Kondratiuk, Director, Digital Patient Solutions, Global Clinical Solutions, AstraZeneca Pharma Poland Sp zoo
Twelve years of experience in clinical trial system delivery implementation, focused on IRT/ RTSM and eCOA/ePRO strategy building and operational delivery. Serving additional guidance in scope of other digital technologies, processes, and services.
Kristi Koontz, Vice President, Global Clinical Operations, Daiichi Sankyo US
Kristine Koontz is the Vice President of Global Clinical Operations at Daiichi Sankyo. Prior to joining Daiichi Sankyo, Kristi was the US pharma and vaccines clinical operations head for GSK. Kristi started her career as a CRA and from there held various roles of increasing responsibility in clinical operations, Development and Medical Affairs. Kristi spent 15 years at AstraZeneca and 8.5 years at GSK before joining Daiichi Sankyo in 2022 with the bulk of that time dedicated to oncology. From 2013-2018, she took a departure from clinical operations to spend time in global medical affairs where she developed medical affairs plans for Votrient® across various indications and integrated the brand into Novartis following the GSK/NVS divesture. Kristi holds a BS in Biology from Penn State University, an MBA from LaSalle University, and a PhD in Business Psychology from The Chicago School. Kristi is a board member of the BeProud Foundation, a non-profit that provides learning opportunities for children in the Philadelphia area. In her free time, she enjoys travelling, reading, listening to leadership podcasts, and spending time with her husband, two daughters, and their dog Chloe.
Tomasz Kosieradzki, Owner & Principal Auditor, Kosieradzki.com; Individual Consultant
KOSIERADZKI.com-GCP Auditing QMS supporting company led by Tomasz Kosieradzki, who started dealing with clinical trials in 1994 as a Clinical Research Associate. He is an educated MD. Since 2003 he has worked as a GCP QA Auditor collecting vast experience in drug-developing organizations (MTZ Clinical Research, Kendle, Janssen, Polpharma Biologics) in and outside EU countries. He specializes in clinical site GCP audits for trials of all Phases (I to IV) and system, sponsor oversight, and vendor audits. He has been using his expert knowledge and experience as a trainer/lecturer. He has been involved in various training projects and a speaker for several industry conferences throughout Europe for the past ten years. He was a co-author of internal training programs, including early development (Phase 1) auditing training program for Janssen Global Clinical QA auditors. He led the training group of the Polish GCP Society. One of his leading activities was sponsor and site preparation for regulatory inspections (EMEA, FDA) through conducting training, pre-inspection audits, and acting as an inspector during mock inspections. He is an MRQA-member of the Research Quality Association (former BARQA) and, Polish GCP Society.
Bari Kowal, Senior Vice President & Head, Development Operations & Portfolio Management, Global Development, Regeneron Pharmaceuticals, Inc.
Bari Kowal joined Regeneron in 2015 and became Head of Global Clinical Operations in 2017. She currently serves as Senior Vice President, Development Operations and Portfolio Management and is responsible for clinical trial strategy and execution, along with overseeing our development shared services functions. She was previously at Pfizer where she held the positions of Vice President, Business Operations and Analytics, and, prior to that, Vice President, Strategic Alliance and Development Operations Lead. Ms. Kowal also served as Vice President, Clinical Operations, on the clinical research organization side of the industry and at a number of biotech organizations in a variety of clinical research roles early in her career. She holds a BS in Biology from the Binghamton University and an MS in Neuroscience from New York University.
Dominik Kraus, PhD, Principal Clinical Scientist, Roche
Dominik Kraus, PhD, is an experienced clinical drug developer with broad clinical experience across various phases of drug development and disease areas. He is currently working as Principal Clinical Scientist in the Early Development Oncology Unit at Roche Pharma Research and Early Development. He discovered his passion for patient inclusivity during his work on the Evrysdi (risdiplam) program in spinal muscular atrophy. This program pioneered an early and systematic partnership with patient communities to co-create truly patient-centric innovations and solutions. He has carried this passion into his work in oncology clinical research, where he has become a strong advocate for patient inclusivity in clinical development. He has been an instrumental partner at Roche for the successful delivery of frameworks to promote patient inclusivity and integrate patient community insights, as well as feedback into early-phase clinical trial design and execution.
Marcy Kravet, Head, Oncology Strategy, Inato
Marcy Kravet is a seasoned executive with a proven track record in leading global teams and innovating for impact. With over 25 years of experience in the pharmaceutical industry, Marcy has held Clinical Operations leadership roles at Bristol Myers Squibb and EMD Serono. She previously was elected by her peers to serve as the co-chair of the Feasibility Consortium, a think tank dedicated to improving data driven approaches to protocol and site feasibility. As Vice President of Strategic Operations at Inato, Marcy works closely with Client stakeholders and Inato’s Customer Success team to integrate strategic objectives with day-to-day operations ensuring site selection and engagement through the Inato marketplace create substantial value for customers.
Maksim Kriukov, Computational Scientist Lead, Integrative Clinical Data Digital R&D, Sanofi Group
I am a Computational Scientist Lead working on building AI-driven analytics for Clinical Development at Sanofi. My team leverages clinical trial and real world datasets to generate insights in drug development. Our goal is to optimize patient subpopulation enrolled in the trial, repurpose existing drugs and improve patient safety.
Amy Kroeplin, MPH, Senior Director, Centralized Monitoring, PPD
Amy Kroeplin is a senior director centralized monitoring in PPD clinical research part of Thermo Fisher Scientific with over twenty years of experience in the clinical research industry. Ms. Kroeplin is responsible for directing and managing the centralized monitoring function which delivers centralized statistical monitoring and risk surveillance for clinical studies. As an extension of centralized monitoring activities, Ms. Kroeplin supports risk-based quality management process oversight including standard operating procedure development for key activities including risk management, quality tolerance limits, centralized monitoring, and reduced source document review/verification.
Kamil Kuhr, Director of R&D GxP Learning Operations, AstraZeneca
Kamil Kuhr (he/they) has 10 years of experience in various parts of R&D. He currently leads a team of experience designer to deliver accessible, sustainable, & compliant learning solutions in Clinical Operations & broader R&D. His ambition is to bring together education & business through the values of inclusion. He co-led an industry conference "Queer Health. Access to Clinical Research & Healthcare", co-authored two chapters for a book "I&D Step by Step. A Practical Guide for Enterprises", & has 5 years of teaching experience at SWPS University in Warsaw where he focuses on applying inclusion & diversity in practice.
Kai Langel, CEO, DEEP Measures
Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal decentralized clinical trial platform. In 2019 Kai co-founded the DEEP initiative to co-create a novel integrated ecosystem for the development, validation and acceptance of digital measures. Kai continues to contribute in an advisory role with DEEP, which is now an independent company. Through his involvement in technical, operational and scientific roles, he has gained deep and holistic understanding of the clinical trial process and the key mechanisms of our ecosystem. Kai brings his entrepreneurial spirit and creative mindset to support Janssen’s global regulatory policy work across a range of topics. Kai has a passion for broad pre-competitive collaboration and is motivated to modernize the ways our broader ecosystem works together to advance the adoption of novel tools and methods to support efficient and patient-centric pharmaceutical R&D.
Sheri Lee, CEO, Principal Consultant, Premier Regulatory Consulting (PRC); Former National Program Expert, FDA
Sheri Lee is the CEO and Principal Consultant at Premier Regulatory Consulting (PRC), a leading boutique firm specializing in providing strategic guidance and expertise to companies worldwide. PRC assists corporations in navigating complex regulatory and quality landscapes to ensure compliance with local and international regulations. Her work at PRC is a culmination of the skills acquired throughout her career. Sheri’s strong background in the pharmaceutical industry was fostered during her time spent at the US Food and Drug Administration (FDA). Sheri spent 10 years at FDA in positions of increasing responsibility with a global scope. At FDA Sheri was the National BIMO Program Expert in the Office of Medical Products and Tobacco Operations. Prior to that she held a position as a National Recall Officer for the Office of Enforcement and Import Operations. During the start of her professional career she worked at non-profits, national and local organizations, hospitals managing clinical trials and developing public health initiatives. After Sheri left the FDA she held various leadership positions in the pharmaceutical industry, at Pfizer, Bayer and Organon to name a few. These roles provided her with invaluable experience managing diverse teams, driving organizational growth, building strategic partnerships, and achieving operational excellence. She brings a deep understanding of the industry's challenges, trends, and regulatory landscape. Her expertise spans a wide range of areas, including recalls, clinical trials, regulatory affairs, pharmacovigilance, and quality. She also has skills in manufacturing quality, ensuring compliance with strict regulations for drugs and devices. Sheri is a native New Yorker, who resides in Atlanta Georgia with her husband Darius and their two children Quinton and Lauren. She also enjoys spending time with family and friends, her two dogs Levi and Milo, practicing yoga and traveling.
Roger Legtenberg, PhD, Co-Founder, Partners4Patients Foundation UG
Driven by a passion for reducing time-to-patient and transforming the life sciences industry, I am dedicated to empowering patients and enhancing the business ecosystem. My work focuses on the human aspect of the Drug Development Cycle, delivering strategic solutions that foster innovation, prioritize patient needs, and promote patient empowerment. I am one of the founders of Partners4Patients Foundation, whose mission is to catalyze goodwill and provide decisive support in setting up and organizing multi-stakeholder alliances while putting patients in the driver's seat. In 2020, I joined admedicum as a Senior Partner, becoming Co-Owner in 2022. Our team excels in patient-focused initiatives, integrating patient-centric practices into daily operations across Europe, the US, and Asia. Our consecutive wins of the International Life Sciences GHP Best Patient Engagement & Access Expert award in 2022 and 2023 underscore our commitment to excellence. With over 20 years in the life sciences sector, including over a decade as CEO of Clinical CRO and Biotech & Medtech startups, my deep industry knowledge is an asset. As CEO of PSR Orphan Experts (acquired by Ergomed Plc in 2017), I advanced progress by implementing lean principles and focusing on Rare Diseases, earning recognition with the CEO Today Europe 2018 award and the International Life Sciences GHP Drug Development CEO award.
Joe Lengfellner, Senior Director, Clinical Research Informatics, Memorial Sloan Kettering Cancer Center
Joe Lengfellner is a dedicated digital health innovator with a passion for applying technology strategies in clinical research. He strives to enhance the experiences of patients, clinicians, and research teams by implementing cutting-edge solutions that streamline processes, bolster communication, and optimize data management. As the Senior Director of Clinical Research Informatics and Technology at Memorial Sloan Kettering Cancer Center (MSK), Joe has spearheaded numerous large-scale research technology initiatives, such as the implementation of MSK's Clinical Trial Management System (CTMS), the development and deployment of eConsent for research, the management of the Electronic Data Capture (EDC) ecosystem, and leading the implementation of Epic for research at MSK. Joe is deeply interested in streamlining clinical data pipelines from EHR systems to research platforms, aiming to reduce the data management workload on sites and simultaneously enhance data quality while also lowering costs for both sites and sponsors. A strong advocate for collaboration, he believes in forging partnerships among clinical research sites, technology vendors, and industry sponsors to develop clinical trial technology solutions that benefit all stakeholders and ultimately accelerate the pace of clinical trial execution. In addition to his role at MSK, Joe leads the Clinical Research Innovation Consortium, a group designed to spearhead innovation within the clinical research industry. Under his leadership, the consortium works to foster collaboration and drive forward-thinking solutions that address the evolving challenges in clinical research. Through his work with the consortium, Joe is committed to shaping the future of clinical research by promoting innovation and excellence across the industry.
Patricia Leuchten, Founder & CEO, Diligent Pharma
Patricia Leuchten is the founder and CEO of Diligent Pharma. She has 30 years of experience in the pharmaceutical industry and is a leading authority on global clinical outsourcing and driving change in clinical trial execution, at scale, through innovative solutions. In 1999, she founded The Avoca Group, whose Avoca Quality Consortium paved the way for Diligent Pharma and the Diligent Qualification Platform. Diligent Pharma is a quality and risk management organization with a central platform that streamlines vendor qualification and enhances risk management in clinical research. The Diligent Qualification Platform shortens clinical trial start-up times while reducing the burden of vendor qualification for trial sponsors as well as their service providers.
Xinyang Li, Senior Data Scientist, Johnson & Johnson
Xinyang has been working as a Senior Data Scientist within JnJ since Dec 2022 supporting several projects within the group utilizing machine learning methods in optimizing clinical operational resourcing. Xinyang obtained her PhD from University of Singapore, Singapore. Before joining ICOA, she worked as a postdoctoral researcher in the Imperial College London, London, UK, focusing on machine learning algorithm development for assistive diagnosis on sensor data and digital health platforms.
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
Micah has 20 years of experience in the biopharma industry. He is an Executive Director at Cambridge Healthtech Institute (CHI) where he is a producer, content developer, and facilitator of the Summit for Clinical Ops Executives (SCOPE), the leading event in the US and Europe for biopharmaceutical industry executives focused on driving innovation in clinical trials and digital health. On a daily basis, he builds a broad community of clinical research stakeholders and industry thought leaders, performs market research, and ascertains ever-changing industry trends in clinical trial optimization, clinical innovation, patient recruitment, digital health, drug development, clinical trial technology, and population health. He is also the Co-founder and Vice President of Community and Business Development of ClinEco. ClinEco unites sponsors, CROs, service providers, and sites on the world's first B2B global clinical trial marketplace so each can expand clinical partnerships. He is continuously onboarding companies and leaders in clinical research to: Explore the Ecosystem. Engage Partners. Exchange Capabilities. SCOPE and ClinEco are owned by Cambridge Healthtech Institute (CHI). Please join our SCOPE and ClinEco communities! https://clineco.io/ www.SCOPEsummit.com www.SCOPEsummiteurope.com
Nadia Lim, Head, Feasibility Strategy & Analytics, Pfizer Inc.
Twenty years of clinical research experience in both Pharma and CRO, focusing on global feasibility, site selection and study start-up for early and late phase clinical trials. With a keen eye towards optimizing clinical trial execution through informed data-driven decisions, Nadia looks to enhance site feasibility by leveraging real-world insights for optimal feasibility planning.
Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis
Robert Loll is SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies. Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 15 years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.
Joachim Lovin, DCT Specialist, Novo Nordisk
Joachim Lövin has worked in the pharmaceutical industry for over 20 years across various therapeutic areas and organizations. During this time, Joachim has worked in different roles spanning over Data Management, Project Management, Process Development, Senior Business Analyst and Clinical Operations. In his current role as DCT Specialist, Joachim focuses on supporting trials including competence development of Clinical Operations, identifying opportunities, and operationalising Decentralised Clinical Trial Elements across Novo Nordisk. Joachim is the Workstream Lead for the Modernizing Clinical Trial Conduct workstream for TransCelerate Biopharma, and a member of the eClinical Forums Trial of the Future. All of Joachim’s work is aligned with his passion to improve patient experience and accelerating clinical trials. Outside of work, Joachim is an avid hiker and leads a youth squad in the Swedish Outdoor Association.
Dawid Lyzwa, Head of Clinical Development, JJP Biologics
The dedicated Head of Clinical Development Team with the knowledge of the biopharmaceutical and clinical trial matters. My experience in Cardiovascular, Renal, and Metabolism (anemia, CKD, T2DM) and Respiratory, Inflammation & Autoimmunity (psoriasis, asthma, COPD, rare dermatoses), Immuno-Oncology (melanoma, osteosarcoma) therapeutic areas in early and late stage development (including work with pediatric populations studies and rare disease studies) give me the ability to chief the cross-functional team, including clinical, operational and financial functions. Proven good communication, combined with attention to detail and collaboration skills allows me to be an effective team leader.
Reamonn Madden, Innovation Capability Director, Global Clinical Operations Innovation, Novartis Pharmaceuticals
Reamonn Madden is a member of the clinical operations innovation group and leads the OneDCT working group within Novartis, leveraging over four years driving the execution of DCT elements in trials and over a decade in trial management and data management.
Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline
Marcin Makowski is the Head of Centralized Monitoring and Data Analytics at GSK. Previously Marcin held similar positions at AstraZeneca and UCB. Last 10 years of Marcin’s career was revolving around establishing and improving Risk Based Monitoring models including centralized monitoring and quality tolerance limits. Marcin holds MD and PhD degrees from the Warsaw Medical University.
Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine
Dr. Malikova is an Assistant Professor of Surgery at Boston University, School of Medicine, and an Executive Director of Research at the Department of Surgery at Boston Medical Center. Dr. Malikova has PhD in Biochemistry with strong background in biomedical sciences. She also holds a Master’s Degree in Clinical Investigation and Master’s of Business Administration in Health Sector Management from Boston University. She has over 18 years of experience in the biomedical product R&D, clinical development, operations and regulatory compliance fields; with the past 11 years on executive level. In her current role as Executive Director, Dr. Malikova macro-manages research programs in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations and compliance, strategic planning and execution oversight of clinical trials; safety and risk management. She is a member of International Society of Pharmacovigilance (ISoP), and currently serves as the Vice-President of NASoP.
Mags McDonagh, Head of Development Operations, Ellipses Pharma UK
A highly qualified (PhD), outcomes-focused, clinical research professional with over twenty years of experience in the pharmaceutical and medical device industry. My career spans a broad range of operationally and strategically focused roles ranging from leading early state oncology and clinical pharmacology study management through to regional operations and outsourcing functional leadership in major pharmaceutical companies such as GSK, MSD, and Takeda, emerging Biopharma such as Ellipses Pharma and CROs including ICON. I have successfully led and managed various cross-functional program teams to support the execution of high-quality, efficient, and reliable clinical programs to support product approval. Extensive experience in the creation and oversight of governance structures and systems/process development and optimisation to support vendor relationship management within the context of a global strategic partnership for a major pharmaceutical company. Leading in the creation of tools and strategies to optimise resource ulitisation within various Clinical Operations teams. Areas of expertise include drug development, operational excellence, vendor relationship, performance management, and process optimisation.
Marisa Minetti, Patient Research Partner, Chiesi Group
Accomplished professional with over 20 years of experience in clinical research in various roles (Clinical Operations, GCP Compliance, Transparency and Disclosure, and Digital Innovation). Marisa is currently working at Chiesi Farmaceutici in the R&D Global Clinical Development department, where she most recently started in her new position as Patient Research Partner, responsible for building and integrating a more patient-informed approach in clinical development.
Melissa Mooney, Director, eCOA Solutions Engineering, IQVIA Patient Ste, IQVIA
Melissa Mooney has over 19 years of experience in the development of eCOA solutions for use in clinical trials. Melissa’s area of expertise is eCOA solution design where she has supported clients and eCOA vendors in developing robust and usable eCOA software solutions that meet eCOA protocol requirements. She also brings a plethora of experience in eCOA requirement gathering, leading eCOA User Acceptance testing, eCOA data management, and BD support.
Shawn Murphy, MD, PhD, Chief Research Information Officer, Mass General Brigham
Dr. Murphy is the Chief Research Information Officer at Mass General Brigham, is Professor of Neurology at Harvard Medical School and serves as Executive Director of the Hospital Integrated Research Organization (HIRO). HIRO accelerates clinical trials with AI technology to prepare data and extract insights at hospitals prior to trial initiation. He received his BS in Chemistry from the University of Notre Dame, and his Ph.D. in Pharmacology and Physiology and MD from the University of Chicago. Dr. Murphy’s research interests include the creation of query methods for healthcare data that enable them to be directly used by scientists even when the data is extremely large. Dr. Murphy was an inventor of Informatics for Integrating Biology and the Bedside (i2b2), a high impact and widely accepted open-source project that focuses on the integration of highly diverse phenotypic, imaging, and genomic data such that new discoveries can be visualized and produced from secondary use of routinely collected healthcare data and be applied to new methods of providing clinical decision and clinical trial support in a learning healthcare system.
Puja Myles, Director, Clinical Practice Research Datalink, CPRD
Puja Myles is Director of the Medicines and Healthcare products Regulatory Agency’s (MHRA) specialist real-world data research service, the Clinical Practice Research Datalink (CPRD). She is a public health specialist and prior to joining CPRD, was a public health academic at the University of Nottingham, UK. She is a fellow of the Faculty of Public Health (UK), a senior fellow of the Higher Education Academy (UK), and has a doctorate in epidemiology. She has been the MHRA’s strategic lead on the development of synthetic data generation approaches and applications since 2017.
Joanna Mysiak, Senior Project Manager, JJP Biologics
Joanna Mysiak is a Senior Project Manager with over a decade of experience in finance, strategy, and consulting in variety of the business areas. Her goal-oriented approach ensures successful project planning and execution, including bid defence activities, contracting, supervision of deliverables, execution of activities within budget and schedule. She already has proven record of successful collaboration and management of recognised, global scientific and (pre)clinical vendors. Her unique combination of business, strategic and scientific skills, allow her to effectively lead the JJP-1212 drug development on program level. Her main focus are tasks connected to early stage of development, including CMC and (pre)clinical areas.
Joao Goncalo Nascimento, Performance Analyst, Predictive Analytics - PRD (OARS), Pfizer Inc.
Finished a master’s in biomedical engineering in 2019 and started working in the International Commercial Department for a Mobile Hospital Software company (performing tasks of project management, product development, commercial and product training and commercial presentations both nationally and abroad, acquiring experience in Hospital Environment and in Bedside Point of Care). In 2021 integrated a Site Feasibility international team at Pfizer, where he was responsible for pivoting site intelligence data into interactive visual platforms, allowing stakeholders to select the optimal sites, using a variety of data sources such as performance / enrollment metrics and diversity. Currently a part of the same team, but after a reorg, a more strategic vision has been required. Defining business level requirements for algorithms for Clinical Trial Site Intelligence / Feasibility projects and organization-wide methodologies for identifying highly performing clinical trial sites were some of the developed tasks. Lately, most developments have been in analyzing the Feasibility process, assessing where generative AI and LLMs can be integrated and seeing to their actual implementation.
Felix Nensa, Essen University Hospital
Felix Nensa is Professor of Radiology with a focus on AI at the Institute for Artificial Intelligence in Medicine, Senior Consultant Radiologist at the Institute for Diagnostic and Interventional Radiology and Neuroradiology and the Scientific Director of the Data Integration Center at the University Hospital Essen. He also has a certified medical qualification in medical informatics. He leads a research group that develops machine learning-based solutions for healthcare. His focus is on practical solutions that need to work in a clinical context. His particular interests include interpretability, user trust and interaction capabilities. He is the founder of the digital health platform SHIP. Felix is speaker and principal investigator of the WisPerMed Research Training Group of the German Research Foundation, board member of the Information Technology Working Group of the German Radiological Society, coordinator of the MII method platform "Open Medical Inference" (OMI), Editorial Board Member and Section Editor AI of the European Journal of Radiology, Associate Editorial Board Member of Investigative Radiology and co-founder of the emerging technologies in medicine (ETIM) congress. He also co-founded several start-up companies.
Liz O’Riordan, PhD, Advocate, Breast Surgeon with Breast Cancer; Best-Selling Author 'The Complete Guide to Breast Cancer: How to Feel Empowered and Take Control & Under The Knife'
Dr Liz O’Riordan was diagnosed with Stage 3 breast cancer whilst working as a consultant breast surgeon in 2015 aged just 40. Her first book, ‘The Complete Guide to Breast Cancer: How to Feel Empowered and Take Control’, was her way of helping women when a local recurrence forced her to retire. Her best-selling memoir, ‘Under The Knife’, shares her experiences of life as a female surgeon before becoming a patient herself. She’s of the top 100 Female Key Opinion Leaders in Oncology to follow on social media, and she hosts the podcast ‘So Now I’ve Got Breast Cancer’. She continues to help patients with evidence-based videos to explain and demystify cancer treatment and talks globally about how to improve cancer care.
Fernando Osorio, Associate Vice President of Medical Affairs, Pharmanovia
Fernando Osorio is a certified orthopaedic surgeon by the Spanish Ministry of Health, with over 18 years’ experience in the pharmaceutical industry, having held positions across medical affairs, clinical development and strategic management, both at national and international structures. Prior to joining Pharmanovia, he held roles at MSD, Novo Nordisk, Servier, and Biogen. Being a physician, Dr. Osorio is passionate about identifying unmet clinical needs, addressing medical care gaps and researching potential solutions for patients and caregivers, establishing relationships with relevant stakeholders like healthcare professionals, patient organisations and advocacy groups.
Ylenia Paleari, PhD, Patient Engagement Manager, Global Rare Diseases R&D Clinical Development, Chiesi Group
Ylenia Paleari, PhD, is a rare disease expert with almost a decade of experience in the industry. She has worked at Chiesi Farmaceutici SpA for five years, leading the Global Rare Diseases R&D Patient Engagement team. Her team is responsible for incorporating the patient perspective into every aspect of the drug development process. With her deep knowledge of the rare disease space and experience in academia and industry, Dr Paleari is committed to translating basic scientific research into effective therapeutic interventions. She has held various positions in academia and industry and moved from pre-clinical to clinical research. In addition to her work at Chiesi, Dr Paleari serves as a local patient association board member dedicated to raising awareness about rare cancers. Dr Paleari is passionate about making a positive impact in patients' lives, and her work reflects that dedication.
Nikos Papachristou, PhD, Senior Manager, Data Science, Quality, Pfizer Inc.
Dr. Nikolaos Papachristou is an experienced data scientist and machine learning engineer with over a decade of experience in biomedical and digital health data, systems, and services. His expertise spans across product management, system design, and evaluation of various biomedical and digital health components. At SCOPE, he will be presenting "Bridging the Gap: Enhancing Clinical Trial Data Integrity through Advanced Log Analytics and Metadata Extraction," showcasing an innovative forensics analysis tool that leverages advanced analytics and metadata extraction from log data to ensure clinical trial data integrity and safety, while fostering collaboration between auditors and data managers.
Barnaby Pickering, Managing Editor, Citeline
After graduating with a master's degree in biomedical engineering from University College London, Barnaby worked as a journalist at Citeline's Medtech Insight and In Vivo publications for three years, writing deep dive features covering the breadth of the medtech sector. He now works for RHA Communications, a boutique PR agency based in Bath, England.
Magda Piskorska, Central Monitoring Lead, GlaxoSmithKline
Magdalena Piskorska is an experienced professional in the field of clinical trials, currently holding the position of Central Monitoring Lead at GlaxoSmithKline. After earning her Mpharm diploma from the Medical University of Warsaw, she embarked on a career in clinical trials, working in various roles across regulatory office, CRO, and pharmaceutical companies. With over 9 years of experience, she has spent the last 3.5 years at GSK, where she plays a crucial role in implementing the Risk-Based Quality Management strategy for both in-house and outsourced studies.
Swapna Pothula, Associate Director, Data Strategy & Management, Global Clinical Operations, GSK
Swapna is a clinical data management professional with a deep understanding of the regulatory requirements and industry standards that govern clinical data management. Over the past 11 years, she has held multiple roles within data management and worked on a wide range of clinical trials (Phase I to IV) with diversified parties such as CROs, pharma, and biotech. She is passionate about initiatives leading to improved trust & acceleration of clinical research, and is enthusiastic about applying her expertise towards the ultimate purpose of getting ahead of disease & transforming patients’ lives.
Johann Proeve, PhD, Chief Scientific Officer, Science & Innovation, Cyntegrity Germany GmbH
Johann has over 40 years of experience as a biopharmaceutical industry expert, mainly in the former international role of Head of Global Data Management at Bayer AG. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.
Allison Proffitt, Editorial Director, Bio-IT World and Clinical Research News
Allison Proffitt is a science writer with a background in biology and chemistry, research experience in cancer biology, and an expanding repertoire in biotech, AI, and battery chemistry. She serves as the editorial director for the Healthtech Publishing media group, a growing collection of online news sites. In addition to Bio-IT World, her work has been published by Nature Biotech, Chemical & Engineering News, and the Economist Intelligence Unit. She has a bachelor’s degree in communication of science, engineering, and technology from Vanderbilt University and a Master’s degree in science and medical writing from Johns Hopkins University.
Léa Proulx, Patient Voice Partner, Strategy, Portfolio & Operations, Roche
Léa Proulx is a scientist by training and has been working at Roche for 10+ years. She's currently working as the Patient Voice Partner within the early Research and Development group. Her role consists of working with Project Teams in early clinical research to ensure Patient Communities are an active partner when teams are discussing early development & clinical strategy, and study design & implementation, taking into account a deeper understanding of patient and caregiver needs. The idea behind this early and systematic partnership is to co-create innovations and solutions that matter to the Patient Community. She truly believes in having a trustful, long-term partnership and collaboration between patients, industry and other stakeholders where everyone has the opportunity to have their voice heard in order to improve outcomes for patient communities and support shaping the healthcare ecosystem of tomorrow.
Sharma Ramanathan Deva Devesa, Principal, ZS Associates, Inc.
With over 10 years of experience in Life Sciences, predominantly in the R&D area, Sharma Ramanathan supports several pharma clients and internal asset development to optimize clinical trials end to end through advanced analytics & data sciences, data management & governance, real-world evidence, and other advisory & consulting services. Sharma has supported several pre and post-market safety and epidemiology studies and regulatory reporting for big pharma.
Edward Ramos, PhD, Senior Director, Digital Clinical Trials, Scripps Research
I currently work in a dual role helping build and establish a Digital Trials Center. The Center seeks to promote and support broad participation in clinical research studies through a "siteless" infrastructure without sacrificing robust data collection by leveraging digital health technologies. This new venture is done in partnership with both Scripps Research and CareEvolution where I sit as the director of digital clinical trials and principal science officer, respectively. Harnessing the expertise from both of these organizations brings the best of both worlds in helping shift the paradigm of how clinical trials are conducted.
Stuart Redding, CEO, Medical Research Network Ltd
Stuart has over 25 years’ experience in the clinical research sector, with experience spanning many disciplines within Sponsor and CRO organizations; including data management, clinical operations, project management, business development, proposals and marketing. Stuart was one of MRN’s founders in 2006 and today leads the company as Chief Executive Officer. Stuart brings incredible insight to the design and delivery of patient-centric, community-based clinical trials, having experienced first-hand the many challenges of the traditional trial model. Stuart is focused on developing and delivering innovative ways to accelerate clinical trials, making it easier for patients and sites to participate in clinical research.
Sylwia Rumniak, Director GCS Study & Digital Solutions, Global Clinical Solutions, AstraZeneca Pharma Poland Sp zoo
With 17 years of experience at AstraZeneca in various roles, I have consistently demonstrated a strong focus on technology. Over the past few years, my professional efforts have been dedicated to the implementation of technological solutions within clinical research. Specifically, I have been involved in the areas of IRT, eCOA, and Spirometry. This journey has allowed me to cultivate a deep understanding of the intersection between technology and clinical research, contributing to the advancement of innovative solutions within the pharmaceutical industry. My passion lies in team leadership and serving as a Line Manager. For over 10 years, I have led diverse teams with a focus on fostering the growth of individuals and their skills. This commitment has allowed me to cultivate an environment where personal and professional development are prioritized.
Karin Schiene, Director, Indication Program Lead, AstraZeneca
Dr. Schiene has 20 years of Clinical Operations experience across both the pharmaceutical industry and CROs. During this time, she held various roles from Clinical Project Manager, RWE Manager, and International Study Leader. Today, she is the Global Feasibility Lead at AstraZeneca, driving optimization in study feasibility and data-driven site selection. Dr. Schiene completed her MSc degree in Biology at the University of Bielefeld, Germany. She also holds a doctorate degree in Natural Science and is a certified PMP since 2015.
Nathaniel Scott, MPhys, MSc, MPE, Medical Physicist, Blue Earth Therapeutics
Nathaniel Scott is a seasoned Clinical Scientist and certified Medical Physics Expert (MPE) specialising in nuclear medicine. Currently with Blue Earth Therapeutics, Nathaniel leads on the scientific aspects of imaging and dosimetry in the clinical development program. With a background in the NHS, Nathaniel later transitioned to overseeing the nuclear medicine physics service within a private oncology network in the UK. Their expertise lies in radiopharmaceutical therapy and dosimetry, with a drive for improving patient care and treatment effectiveness. Driven by a passion for advancing healthcare through science, Nathaniel strives to make a positive impact in his field, blending theoretical knowledge with practical skills to drive innovation.
Sapna Shah, Head of Global Clinical Operations Americas, Telix Pharmaceuticals
Sapna Shah, Sr. Director, Clinical Operations Americas at Telix Pharmaceuticals, a commercial-stage biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic ('theranostic') radiopharmaceuticals. A results driven leader having over 15+ years of extensive experience in clinical research within the healthcare industry. As a seasoned professional in this field, I am committed to optimizing clinical processes, drive efficiency and ensure compliance with regulatory standards. As the Sr. Director, Clinical Operations Americas at Telix, I oversee the strategic planning and execution of global clinical trials leveraging my expertise to streamline operations and optimizing clinical trials. Throughout my career, I have successfully managed complex clinical trials across various therapeutic areas, ranging from early-phase development to post-marketing studies. Holding an MD from Windsor University, underscoring my commitment to continued professional development and staying abreast of emerging trends in clinical research to ultimately help patients having an unmet medical need. Aside from work, I am a mother to two beautiful girls, age 5 and 13. We love biking, hiking, reading and of course, family movie time on Friday nights!
Rosia Shah, MD, Medical Lead, VCTC
Medical lead for a decentralised clinical trial site. Consultant Obstetrician and gynaecologist. Dual qualified in womens health and general internal medicine. Passionate about improving access to clinical trials across all patient groups and making research part of communities.
Dan Shannon, Chief Experience Officer, Operations, Greenphire
As Chief Experience Officer, Dan is responsible for overseeing Greenphire’s business operations teams, defining customer engagement and driving operational excellence to ensure a best-in-class customer experience for existing and future clients. He is committed to building and scaling the team to drive ongoing adoption and maximizing the value delivered from our software solutions and services around the world.
Dan has more than 25 years of experience in the clinical trial industry, having started his career managing early phase trials at Schering-Plough, to more recently holding senior leadership positions at Veeva and Medidata. Dan’s responsibilities have included leading Professional Services, Customer Success, Customer Support, and Education Services teams in the US, Europe and Asia.
Dan earned a Bachelor of Science degree in Chemistry from Rutgers University, a Master of Science degree in Environmental Science from New Jersey Institute of Technology and a Master of Business Administration degree from Duke University. He currently resides in New Jersey with his wife and three children.
Mary Smith, Senior Director, Clinical Portfolio Execution, Seqirus A CSL Co.
Mary Smith is the Senior Director Clinical Portfolio Execution at CSL, responsible for the vaccines therapeutic area. She is a dedicated professional with passion for public health and infectious diseases. She has a solution oriented working style and takes pride in successfully leading teams through operational challenges and reliably delivering on the clinical trials. She enjoys the dynamics that come along with early planning, start-up and enrollment and she loves working with diverse teams, leveraging the different strengths and perspectives to maximize operational delivery. Mary has more than 15 years of experience in the pharmaceutical industry and holds a Master of Science in Biomedical Sciences from the Radboud University in Nijmegen, the Netherlands.
Zachary Smith, Senior Data Scientist, Tufts Center for the Study of Drug Development
Zak Smith works on a variety of Tufts CSDD studies focusing on drug development performance, efficiency, economics, and innovation adoption. Many of these projects involve creating, compiling, and analyzing very large datasets. Zak completed his BS at Florida Southern College and received his MA from Brandeis University. He is a former research analyst at Tufts CSDD and has worked as a research assistant at Harvard University and at the University of Massachusetts.
Nicole Stansbury, Senior Vice President, Global Clinical Operations, Premier Research; Co-Lead, Risk-Based Monitoring Working Group, Association of Clinical Research Organizations (ACRO)
Nicole Stansbury, Senior Vice President, Global Clinical Operations, is responsible for oversight of clinical operations which includes clinical strategy and delivery, study start up, central monitoring, and site management and risk-based monitoring at Premier Research. She leverages an innovative, data-driven approach and more than 25 years of industry experience to help sponsors address the rapidly evolving demands of the clinical development industry. In her role, Stansbury is focused on finding ways to simplify process and improve technology adoption to decrease the time, cost, complexity, and risk of delivering clinical research. Prior to joining Premier Research, Stansbury held various CRO leadership positions where she was instrumental in the strategic implementation of risk-based monitoring, central monitoring and continuous improvement of clinical operations processes. Stansbury has been co-lead for the Association of Clinical Research Organizations Risk-Based Monitoring (ACRO RBM) Working Group working with TransCelerate and the FDA since 2014. She holds a Bachelor of Science from Texas A&M and a Lean Six Sigma - Yellow Belt certification.
Lucina Tabasso, Senior Project Manager, Patient Education, Patient Recruitment&Retention, ERCULES
I am a Senior Patient Education Project Manager at Ercules. I have over 20 years of experience in patient education and over 10 years of experience in developing and managing projects that support recruitment and retention in international clinical trials. I have lead the development and implementation of strategies for patient and site engagement in multiple adult and pediatric trials. The heart of our strategies is patient education: ensuring patients (caregivers, family members, children...) receive adequate and complete information on the condition and on the study.
Based on the study protocol and specific study population, I lead our team of medical writers, designers and illustrators, in the development of a strategy that is tailored to the unique requirements and needs of the study. In our strategies we include both standard educational materials and innovative digital products/services, such as online advertising, engagement apps and videogames.
Laura Trotta, VP Research Operations and Statistical Innovation, Research, CluePoints SA
Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as Vice President of Research in January 2022, where she leads a team of research scientists responsible for developing new statistical and machine learning algorithms to assess the quality of clinical trial data. Laura holds a Master’s degree in Biomedical Engineering and a PhD in Applied Mathematics from the University of Liège, Belgium.
Aditya Tyagi, Project Manager, Pistoia Alliance
Aditya is a seasoned Project Manager with over 17 years of experience in global clinical trials, supervising projects across various phases and regions within CRO and academic institutions. He has managed projects in the USA, Europe, Asia, and beyond, gaining a keen understanding of the complexities and challenges in international clinical research. Currently, Aditya works as a Project Manager at Pistoia Alliance, where he plays a crucial role in developing innovative solutions to streamline clinical trial processes. His notable work on the ClinOps Ontology project highlights his deep understanding of semantic data models and their applications in enhancing operational efficiency. Throughout his career, Aditya has actively contributed to the advancement of clinical research, presenting at numerous conferences and forums. With a solid foundation in both clinical research and project management, he is well-equipped to provide valuable insights and strategies for addressing the unique challenges faced by today’s clinical trial professionals.
Mohammad Umarfaruque, Data Science Consultant, ZS Associates
Mohammad Umarfaruque, a Data Scientist at ZS Associates in India working with Johnson & Johnson, specializes in developing data-driven data science solutions to optimize clinical trials for pharmaceutical clients. He holds Bachelor's and Master's degrees from the Indian Institute of Technology (IIT) Madras, India, and has five years of experience in using Data Science and Machine Learning to design, implement, and manage end-to-end clinical trial pipelines. He collaborates with pharmaceutical clients to provide customized process enhancements. His technical expertise spans Statistical Modeling, Probabilistic Programming, Operations Research, Natural Language Processing (NLP), Generative AI, Recommender Systems, and Advanced Machine Learning.
Hilde Vanaken, Head EFGCP eConsent Initiative, EFGCP - European Forum for Good Clinical Practice
Hilde is a passionate industry leader with +30 years hands-on expertise in various drug development domains. She has a track record of turning large and complex programs into success stories through knowledge, collaboration, and persistence. Examples include J&J’s flagship for Patient Engagement and Smart Technologies (iSTEP) and Transcelerate eConsent. Hilde enables incremental trial efficiencies and first-of-its kind partnership models. Hilde makes the impossible possible. Currently, Hilde is heading up the non-profit multistakeholder European Forum GCP (EFGCP) eConsent initiative, bringing together over 50 companies, next to her role as TCS Head Industry leaders Life Sciences. Hilde is a PhD in Medical Sciences, Engineer in Microbiology, and Master in Environmental Sciences, all obtained from the University of Leuven in Belgium.
Maria Veleva, Founder & Managing Director, Velev Consulting Ltd.; Individual Consultant
Maria Veleva established Velev Consulting Ltd. in 2020, focusing on clinical quality solutions and consulting services tailored to international Biopharmaceutical and CRO companies. Before this venture, Maria served as the Director of Quality Management at IQVIA (formerly Quintiles) for over two years. In this capacity, she led quality oversight for clinical operations across ten key European markets, developing training materials and hosting 'Lessons Learned' sessions for operational teams. Maria also played a pivotal role in preparing for regulatory events and contributed to the development and review of SOPs, policies, tools, and processes as a member of the Global Quality Management Board. With a Medical Doctor's degree from Sofia Medical University, Maria is dedicated to lifelong learning, participating in various courses, coaching programs, and mentoring initiatives. At IQVIA, she served as a coach and mentor to numerous individuals and continues to provide pro bono mentorship through LinkedIn. A member of esteemed professional organisations like the Research Quality Association (RQA), the European Forum for Good Clinical Practice (EFGCP), and the Bulgarian Association of Clinical Research (BACR). With over two decades of experience in clinical research spanning diverse global roles, Maria's expertise encompasses team management, project leadership, and quality assurance. She has conducted audits worldwide, including support for European Regulatory Authority Inspections. Currently, Maria serves as a Principal Consultant at Velev Consulting Ltd, while also contributing as a Chair of the RQA Consultants Group, a member of the Quality Working Group at the EFGCP, and others.
Patrycja Wasikiewicz, Director Global Clinical Solutions, AstraZeneca
Patrycja Wasikiewicz is an ambitious pharmacist. In addition to obtaining a Master's degree in Pharmacy, she has completed postgraduate studies in the field of Computer Systems, Programming, and Databases. She applies the knowledge gained to introduce numerous improvements in processes and technologies used in clinical trials. Since joining AstraZeneca in 2017, Patrycja has been actively gaining new skills and has developed a strong passion for innovation and digital solutions in clinical trials. With her expertise gained as Spirometry, Cardiac Safety, Medical Imaging, and eCOA Process Owner, Patrycja has acquired extensive knowledge of the technologies used in AstraZeneca's studies. In her current role, Solutions Implementation Team Leader, she is focusing, among others, on driving transformative and strategic improvements. Outside of work, she spends her time with her husband and son. She loves sushi, traveling, and Christmas films.
Robina Weermeijer, Global Clinical Trials Diversity & Inclusion Lead, Boehringer Ingelheim
Robina Weermeijer has over 9 years of experience in the pharmaceutical industry. She has held positions in Communications and Patient Engagement in which she worked with patient organizations in a range of disease areas. Currently, she is focused on increasing diversity, equity, and inclusion in clinical trials globally at Boehringer Ingelheim. Her passion for driving positive change in the healthcare industry is rooted in her belief in the power of collaboration and patient-centered care. She firmly believes that by truly listening to patients of diverse backgrounds, and the people around them, pharma can make an even bigger positive impact in people’s lives.
Thomas Westgate, Director, Strategic Feasibility, Clinical Research, PPD, part of Thermo Fisher Scientific
Tom has 16 years industry experience, including the last 11 years in Strategic Feasibility with PPD, where he is a Director. He has an interest in innovative technological solutions to the challenges of site identification, and is passionate about improving the way we connect clinical trial opportunities to potential sites, investigators and patients.
Ali Wherry, Director, Clinical Operations, Science37
Ali Wherry currently serves as Director of Operations at Science 37, with over 10 years of experience in clinical research. Specializing in decentralized trial optimization, Ali has led multi-million dollar projects with global reach, ensuring successful FDA inspections and enrollment of thousands of participants across multiple portfolios. Ali has a Masters in Clinical Research and Product Development from the University of Chapel Hill, Wilmington.
Linda White, Associate Director, Risk-Based Quality Management, Jazz Pharmaceuticals
Linda White is an Associate Director of Risk-Based Quality Management at Jazz Pharmaceuticals, with over 15 years of experience in Clinical Operations. Current focus has been on training RBQM process and technology to all departments involved in clinical trials. As part of the leadership of a growing team, we aim to build a culture of Quality by Design and critical thinking into trial design and management.
Madeleine Whitehead, Process Excellence Leader, Product Development Quality Solutions, Roche Products Ltd.
Madeleine Whitehead has over 15 years of industry experience focusing on clinical process excellence, gained in both Sponsor and CRO settings. Madeleine is passionate about robust, user-centric processes which enable a compliant risk-based approach in the conduct of clinical studies. In her current role at Roche, Madeleine is dedicated to supporting Process Owners of global clinical development processes to created innovative, effective, and efficient mechanisms to operationalize clinical studies. Madeleine is a devotee of Good Clinical Practice who works to promote the understanding, appreciation, and application of GCP in clinical activities.
Shyard Wong, Head, Clinical Quality & Continuous Improvement, Sanofi
A physician by training who graduated from the National University of Singapore in 1991, Shyard Wong rotated through a series of clinical postings in both the public and private healthcare sectors in Singapore and then undertook a career switch to become a full time healthcare administrator in National Healthcare Group of, one of the 2 healthcare clusters in Singapore overseeing the development of clinical programs across the continuum of patient care as well as in the administration of research and development. In 2006, he joined sanofi-aventis as a Medical Advisor of the Southeast Asia Clinical Study Unit and subsequently took over as Head of the unit in 2008. In 2011, his role expanded to head of the CSU Asia Pacific region putting special focus on developing and expanding the CSU in China. After spending 7 years in that role, Shyard moved to undertake the of Head of Clinical Quality and Continuous Improvement in 2018.
Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC
Ms. Yanak is a Pharmaceutical & Central Lab executive known for successfully translating scientific strategy into clinical operations, via technology and innovation. She developed an Innovation Operating Model to pilot digital health and other ideas to transform drug development, and envisioned and led a multi-year strategic program to operationalize Precision Medicine at a Top 5 pharma, including transformation of the end-to-end specimen management policy, process, and technology infrastructure: standardizing protocols, digitizing informed consent, developing virtual specimen tracking, and using artificial intelligence to automate clinical study reports to expedite creation of big datasets for mining new biomarkers. Brenda has led transformative initiatives at several major companies, and acts as an Advisor to the Summit for Clinical Operations Executives (SCOPE).
Tony Yordanov, Clinical Operations Program Director, Novartis
Business professional with over 14 years of expertise in the pharmaceutical industry. Expert at clinical trial monitoring and site management, clinical project and portfolio management, quality, and operational excellence. Extensive experience in various leadership roles on county, regional and global level, driving diverse teams through change and delivering high-impact results. Holds a master’s degree in pharmacy from the University of Sofia. Currently the Clinical Operations Program Director at Novartis, responsible for delivering robust data driven feasibility and early planning, process optimization and building a global feasibility community. Passionate about innovation, collaboration, and continuous improvement of the medicines development process by leveraging new meaningful technologies, combining data with human insights to ultimately deliver solutions for patients.
Jytte van Huijstee, Director Clinical Trial, Operations, myTomorrows
Jytte is Director Clinical Trial Operations at myTomorrows. She works together with Biopharma clients and the internal myTomorrows team to set up patient recruitment and pre-screening programs for clinical trials.
After studying Biomedical Sciences, Jytte started working in clinical research in 2016. She specialized in monitoring and managing oncology trials, working closely together with trial sites and Sponsors. In February 2023 she joined myTomorrows, because she was inspired by the company's mission to help patients and physicians discover and access clinical trials.
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